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Clinical Trial of TQB3002 in Patients With Advanced Cancers

C

CTTQ

Status and phase

Enrolling
Phase 1

Conditions

Advanced Cancer

Treatments

Drug: TQB3002 Tablets

Study type

Interventional

Funder types

Industry

Identifiers

NCT06662760
TQB3002-I-01

Details and patient eligibility

About

This is a Phase I study to evaluate the safety, tolerability, and efficacy of TQB3002 in subjects with advanced cancers

Enrollment

150 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Subjects voluntarily joined this study, signed the informed consent form, and had good compliance;
  • Age: ≥ 18 years old; Eastern Cooperative Oncology Group (ECOG) score: 0-1 ; Expected survival of more than 3 months;
  • Histologically or cytologically diagnosed with advanced cancers
  • Subjects with advanced malignancies who have failed standard therapy or lack effective treatment
  • Major organs are functioning well;
  • Female and male subjects of childbearing potential should agree to practice contraception for the duration of the study and for 6 months after the end of the study.

Exclusion criteria

  • Current concomitant presence of other malignancies within 5 years prior to the first dose;
  • Unresolved toxicity above CTCAE Grade 1 due to any prior anti-tumor therapy
  • Significant surgical treatment, biopsy, or significant traumatic injury within 4 weeks prior to the first dose
  • Long-term unhealed wounds or fractures
  • Cerebrovascular accident (including transient ischemic attack, intracerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism within 6 months prior to the first dose
  • Swallowing dysfunction, active gastrointestinal diseases or other diseases that significantly affect the absorption, distribution, metabolism and excretion of the study drug, or previous subtotal gastrectomy
  • A history of psychotropic drug abuse and cannot be abstained from or have a mental disorder
  • Subjects with any severe and/or uncontrolled disease

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

150 participants in 1 patient group

TQB3002 Tablets
Experimental group
Description:
TQB3002 Tablets, 28 days as a treatment cycle
Treatment:
Drug: TQB3002 Tablets

Trial contacts and locations

11

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Central trial contact

Qing Zhou, Doctor

Data sourced from clinicaltrials.gov

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